InstantGMP Compliance Series - Supplier and Vendor Qualification
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Transcript of InstantGMP Compliance Series - Supplier and Vendor Qualification
![Page 1: InstantGMP Compliance Series - Supplier and Vendor Qualification](https://reader036.fdocuments.in/reader036/viewer/2022082605/5558bb87d8b42aa52a8b4eee/html5/thumbnails/1.jpg)
InstantGMP Compliance Seriesfor cGMP Dietary Supplements
Supplier and Vendor Qualification
![Page 2: InstantGMP Compliance Series - Supplier and Vendor Qualification](https://reader036.fdocuments.in/reader036/viewer/2022082605/5558bb87d8b42aa52a8b4eee/html5/thumbnails/2.jpg)
Electronic cGMP Manufacturing Execution System
Problems - Qualifying Vendors
• FDA issued Warning Letters for GMP violations of Dietary Supplement Health and Education Act
• Failure to adequately identify incoming dietary ingredients
• Not establishing reliability of suppliers COA• Not validating testing done by supplier
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Electronic cGMP Manufacturing Execution System
Why Qualifying Vendors is Important
• Essential to show materials come from approved vendors
• Reduces amount of final product testing needed during or after production
• Reduces risk of final product being contaminated or adulterated
![Page 4: InstantGMP Compliance Series - Supplier and Vendor Qualification](https://reader036.fdocuments.in/reader036/viewer/2022082605/5558bb87d8b42aa52a8b4eee/html5/thumbnails/4.jpg)
Electronic cGMP Manufacturing Execution System
How to Improve
• Establish a Vendor Verification program• Program should include:
– Audits of suppliers and vendors– Confirming the test results of certificates of analysis– Re-qualifying the vendor at periodic intervals
• Check that COAs include specifications for identity, description, limits on contaminants, results, strength, and tolerances
![Page 5: InstantGMP Compliance Series - Supplier and Vendor Qualification](https://reader036.fdocuments.in/reader036/viewer/2022082605/5558bb87d8b42aa52a8b4eee/html5/thumbnails/5.jpg)
Electronic cGMP Manufacturing Execution System
DSHEA Requirements
• Conduct at least one test to verify identify of each in-coming dietary ingredient
• COAs for other components are OK if:– Test results are confirmed– COA contains test, methods, acceptance limits and
results– There is documentation on how supplier was qualified– Periodic requalification is conducted– Quality reviews and approves supplier
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Electronic cGMP Manufacturing Execution System
Quality Surveys and Audits
• GMP Quality Survey– Used to pre-qualify a vendor before deciding on a
more formal audit– An example can be found at
www.instantgmp.com/Quality-Assurance-Templates
• On-Site Audit– Conducted by a Quality professional– Defines the authorized services or product
![Page 7: InstantGMP Compliance Series - Supplier and Vendor Qualification](https://reader036.fdocuments.in/reader036/viewer/2022082605/5558bb87d8b42aa52a8b4eee/html5/thumbnails/7.jpg)
Electronic cGMP Manufacturing Execution System
Vendor Verification Program
• Qualification of all suppliers including components, ingredients and labels
• Periodic audits and re-qualifying of vendors• Confirmation of vendor's test results and COAs• Reviews of specifications, procedures, and lab controls• Regular review of vendor’s documentation
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Electronic cGMP Manufacturing Execution System
Audit Plan
• Agenda – list of areas and items to be reviewed• Documents Requested prior to Audit• Organizational structure• Facility inspection• Quality systems review• Documentation Control and Record Keeping• Training/ Personnel
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Electronic cGMP Manufacturing Execution System
Audit Plan - Manufacturing
• Calibration procedures and documentation• Procurement and Materials• Processing and In-process inspection • Final inspection and testing• Distribution• QC Laboratory• Example at www.instantgmp.com/Quality-
Assurance-Templates.
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InstantGMP™
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Center at www.instantgmp.com